BioWrist BW01-RN05

GUDID 00813845020979

BioWrist Procedure Kit

SKELETAL KINETICS LLC

Bone matrix implant, synthetic Bone matrix implant, synthetic Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00813845020979
• NIH Device Record Key: c25587c5-d51b-4eaf-8126-b34e937e3da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioWrist
• Version Model Number: BW01-RN05
• Catalog Number: BW01-RN05
• Company DUNS: 140071411
• Company Name: SKELETAL KINETICS LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(972)677-4655
• Email: cs@skeletalkinetics.com
• Phone: +1(972)677-4655
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813845020979 [Primary]

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-06-29
• Device Publish Date: 2015-10-30

Devices Manufactured by SKELETAL KINETICS LLC

• 00813845021105 - CranioSculpt: 2019-12-25 CranioSculpt C 3cc
• 00813845021112 - CranioSculpt: 2019-12-25 CranioSculpt C 5cc
• 00813845021129 - CranioSculpt: 2019-12-25 CranioSculpt C 10cc
• 00842528100172 - OsteoMed: 2018-06-29 OsteoVation RM-EX, 5cc
• 00842528100189 - OsteoMed: 2018-06-29 OsteoVation RM-EX, 10cc
• 00842528104156 - OsteoMed: 2018-06-29 OsteoVation RM-EX Inject, Bone Void Filler, 3cc
• 00813845020009 - OsteoVation: 2018-06-29 OsteoVation EX Inject 2cc
• 00813845020016 - OsteoVation: 2018-06-29 OsteoVation EX Inject 3cc